Mary Kay Margolis

• Evidera

Background: Uterine fibroids (UF) are associated with significant health-related quality of life (HRQL) impact. This study examined the impact of UF symptoms on HRQL. Methods: An online cross-sectional survey of 18 to 49 year US women was conducted and collected demographics, UF prevalence, symptoms, and HRQL using the UFS-QOL. Descriptive statisti...

Objective: To assess the psychometric performance of the 4-week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life Questionnaire (UFS-QoL), a patient measure of the severity of uterine fibroid (UF) symptoms and their impact on health-related quality of life (HRQL). Methods: This was a retrospective analysis of Phase 2a...

Aim: To determine laxative utilization over time among chronic noncancer pain patients with opioid-induced constipation (OIC). Setting: A prospective longitudinal study conducted in the USA, Canada, Germany and UK. Methods: Patients on daily opioid therapy for treatment of chronic noncancer pain with OIC were recruited from clinics to complete...

Clinical management and clinical trials of patients with overt hepatic encephalopathy (OHE) are compromised by lack of standardized and reproducible tools for its clinical diagnosis or for caregiver (CG) identification of OHE manifestations which merit medical evaluation. Using an iterative Delphi method, Steering Committee and international hepato...

Background: Little is known regarding the burden of opioid-induced constipation (OIC) among patients who suffer from cancer-related pain. Methods: A prospective longitudinal study was conducted among cancer patients in the United Kingdom (UK), Canada, and Germany, which included medical record data abstraction, Internet-based patient surveys, an...

BACKGROUND: Greater satisfaction with medication is associated with better adherence; however, specific to opioid-induced constipation (OIC), data on the relationship between medication satisfaction and efficacy are lacking. OBJECTIVE: To understand satisfaction with therapy among patients with chronic noncancer pain and OIC. METHODS: A prospective...

Background The impact of sufficient laxative use on opioid-induced constipation (OIC) is not known.AimTo understand the experience and symptom burden over time among chronic non-cancer pain patients with OIC who are sufficient laxative users.MethodsA prospective longitudinal study was conducted in United States, Canada, Germany and UK which include...

Estimate rate of laxative inadequate response (LIR) over time among patients with chronic noncancer pain with opioid-induced constipation (OIC). A prospective longitudinal study was conducted in United States, Canada, Germany, and United Kingdom. Patients on opioid therapy for ≥4 weeks for chronic noncancer pain and OIC completed an Internet-based...

Objective: The prevalence of non-steroidal anti-inflammatory drug (NSAID) and concurrent gastroprotective agent (GPA) use in the US is not known. As such, the prevalence of GPA use among arthritis patients taking NSAIDs was examined. Methods: Men and women aged ≥ 40 with self-reported arthritis and members of a web-based community panel were inv...

The Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire, a validated patient-reported outcome measure of fibroid symptoms and health-related quality of life, was modified for use posthysterectomy. This study was conducted to psychometrically validate the UFS-QOL-Hysterectomy questionnaire for potential use in comparative effectivene...

To further examine the reliability, validity and responsiveness of the uterine fibroid symptom and quality-of-life (UFS-QOL) questionnaire among women with and without uterine fibroids. A multicenter, non-randomized, prospective study was conducted with women undergoing treatment for uterine fibroids (fibroid treatment group [FTG]) and normal contr...

The Sexual Desire Relationship Distress Scale (SDRDS) was developed to address the need for a patient-reported outcome (PRO) measure of sexual distress associated with hypoactive sexual desire disorder (HSDD). The SDRDS is a 17-item PRO that includes items related to personal distress and distress related to relationship with partner. The aim of th...

To estimate the prevalence of overactive bladder (OAB) in men and women in the United States (US) to determine whether there were racial differences. This was a secondary analysis of data from the EpiLUTS (Epidemiology of Lower Urinary Tract Symptoms) survey, an Internet-based cross-sectional, population-representative epidemiologic survey conducte...

Background: Overactive bladder (OAB) consists of the symptoms of urinary urgency (with or without urgency incontinence) and increased urinary frequency and nocturia. As OAB is defined by symptoms, the patient is the best source of information for assessing the impact of the condition on health-related quality of life (HR-QOL). This assessment can...

The Female Sexual Function Index (FSFI) has consistently been shown to have discriminant validity, test-retest reliability, and internal consistency as a measure of female sexual function. However, the content validity (relevance, clarity, comprehensiveness) of the instrument in women with hypoactive sexual desire disorder (HSDD) must also be estab...

Patient-reported measures of visual function are increasingly incorporated into clinical trials of new treatments for age-related macular degeneration (AMD). Limited information is available regarding the associations between distance visual acuity (VA), reading speed, or contrast sensitivity and the National Eye Institute Visual Function Questionn...

OBJECTIVE: Overactive bladder (OAB), a bothersome condition that affects many, is best measured using patient-reported outcomes (PROs). This study was conducted to examine the psychometric properties of 5 brief OAB measures: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Subject's Assessment of Condition (SAC), Subje...

Evaluation of acute rhinosinusitis treatment effectiveness is based on patient-reported relief of symptoms. This study was designed to develop a multiattribute utility scoring algorithm for the Major Symptom Score (MSS) and secondarily to evaluate the psychometric characteristics (i.e., validity and responsiveness) of the MSS Utility Index (MSSUI)....

BACKGROUND: Evaluation of acute rhinosinusitis treatment effectiveness is based on patient-reported relief of symptoms. This study was designed to develop a multiattribute utility scoring algorithm for the Major Symptom Score (MSS) and secondarily to evaluate the psychometric characteristics (i.e., validity and responsiveness) of the MSS Utility In...

Erectile dysfunction (ED) is the most common male sexual dysfunction and has a negative impact on masculinity and self-esteem. Phosphodiesterase type 5 inhibitors, including sildenafil, are the first-line treatment option for ED. Providing appropriate information regarding suitability for using sildenafil is important. The purpose of this study was...

The purpose of this study was to assess the validity of the Urinary Sensation Scale (USS) in men with overactive bladder and voiding symptoms (OAB-LUTS) and women with overactive bladder (OAB). Data from two OAB clinical trials of tolterodine were used. The USS, a 5-point scale, assesses the amount of urinary urgency associated with each urination....

The purpose of this study was to validate a short awareness tool to assist patients in identifying if they have bothersome overactive bladder (OAB) symptoms. This secondary analysis study utilised data from a cross-sectional study of adult patients presenting for primary care visits. Patients completed an 8-item OAB screener. The clinician probed f...

Erectile dysfunction is a treatable condition that affects a large proportion of men. Most men do not seek medical help for their ED because of embarrassment or social stigma that may lead some men to self-treat. To evaluate men's ability to self-assess their suitability for 50 mg sildenafil use after reviewing patient information materials. Patien...

: As upper gastrointestinal (GI) symptoms are common with the use of low-dose aspirin (low-dose acetylsalicylic acid [LDASA]; 75-325 mg/day), this exploratory qualitative study evaluated the upper GI symptom experience and attribution of symptoms among patients taking LDASA for coronary artery disease (CAD) or known CAD risk factors. : Focus groups...

Valid and reliable questionnaires must be used to accurately assess patients' satisfaction with overactive bladder (OAB) treatment. This study evaluated the reliability and validity of the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q). This was a secondary analysis of clinical study data of patients randomized to darifenacin or darifena...

Immunosuppressive therapies have burdensome side effects which may lead to sub-therapeutic dosing and non-compliance. Patients on different immunosuppressant regimens may feel less bothered by Gastrointestinal (GI) side effects or report better health-related quality of life (HRQL). We evaluated the reliability and validity of two GI-specific outco...

Patient-reported outcomes (PROs) are measures of patients' health status provided directly by patients and when utilized in clinical trials, multiple language versions may be needed. The overactive bladder questionnaire (OAB-q), a self-administered PRO assessing symptom bother and health-related quality of life (HRQL) in patients with OAB, was deve...

Introduction: Overactive bladder (OAB) is quite prevalent and significantly affects health-related quality of life and daily functioning. Aim: The impact of OAB on sexual health is currently not known. This qualitative study was conducted to gain a thorough understanding of OAB's impact. Methods: Sexually active women with continent or inconti...

To assess sexual health, relevant, valid, and reliable questionnaires need to be used. To assess the relevance and content validity of three sexual health questionnaires in women with overactive bladder (OAB) and urinary incontinence. Sexual Quality of Life Questionnaire--Female (SQoL-F), Sexual Function Questionnaire (SFQ), and Pelvic Organ Prolap...

Gastrointestinal (GI) side-effects occur frequently as a result of immunosuppressant regimens used in renal transplant patients. Little effort has been made to quantify the impact of these side-effects on patients' health-related quality of life and symptom severity. To assess the psychometric characteristics of two GI-specific outcome instruments...

The aim of this study was to identify key aspects of the impact of cognitive impairment on patients with mild cognitive impairment (MCI) and mild probable Alzheimer disease (AD) and their informants, and identify overlap and differences between the groups. Structured focus group discussions were conducted with MCI patients, AD patients, MCI informa...

Patient-reported outcomes assessment enhances the understanding of disease impact in a range of disorders. At mild levels of cognitive impairment the patient perspective on functioning, behavior and symptoms can be particularly valuable for syndrome characterization when clinical and neuropsychological findings are limited. We have evaluated the ps...

Overactive bladder (OAB)--a syndrome characterized by urinary urgency, with or without urge incontinence, urinary frequency and nocturia--is estimated to affect 10% to 20% of the US and European populations. This study was carried out to validate a patient-administered screening awareness tool to identify patients with bothersome OAB symptoms. Pati...

The analgesic effect of long-acting opioids, such as transdermal fentanyl, has been demonstrated in patients with cancer, neuropathic pain and chronic low back pain (CLBP). However, the broader effect of long-acting opioids on the patient's health-related quality of life (HRQoL) is less well known. To evaluate HRQoL outcomes in CLBP patients treate...

To quantify the magnitude of child, caregiver, and family distress associated with hospitalization for severe respiratory syncytial virus (RSV) and the posthospitalization recovery period. A prospective study of 46 RSV-hospitalized infants and children < or =30 months of age with a history of prematurity (gestational age of < or =35 weeks) and 45 a...

Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting approximately 2.2 million people in the US. The presentation of AF ranges from asymptomatic to severely symptomatic. When symptomatic, AF has been shown to have an adverse impact on health-related quality of life (HR-QOL) and to result in increased healthcare costs. The objec...

Intermittent claudication resulting from peripheral arterial disease (PAD) can substantially impair walking function. The Walking Impairment Questionnaire (WIQ) assesses patient self-reported difficulty in walking. Currently this questionnaire is validated for interviewer administration only. Since this can be burdensome in a large clinical trial,...

Improving and maintaining health-related quality of life (HRQL) is an important goal of treatment in patients with chronic obstructive pulmonary disease (COPD). This outcome takes on even greater significance as the disease progresses and the likelihood of a significant improvement in pulmonary function declines. The purpose of this paper is to pro...

RESULTS: The average VAS value at baseline was 0.65 (SD = 0.19), 0.83 (SD = 0.14) at the end of the study and the average change score from baseline to end of study for the VAS was 0.17 (SD = 0.20). The differences between the VAS value and the derived preferences ranged from-0.07 to 0.02 at baseline. Three of the five 95% confidence intervals (CIs...

OBJECTIVE: To evaluate the psychometric characteristics of the Acute Bronchitis Symptom Severity Scale (ABSS). METHODS: The ABSS is a seven-question, bronchitis specific, instrument. Responses are measured on a scale of 0–4. The total score is calculated as the mean of the seven responses with higher scores indicating greater distress. The ABSS was...

Clinically objective measures such as visual acuity or visual field provide an assessment of a patient’s visual status. However such measures may not reflect the degree of visual impairment the patient experiences in his or her daily activities. Visual impairment has been shown to have negative effects on health-related quality of life (HR-QOL) and...

Includes bibliographical references (leaves 22-24). Thesis (M.P.H.)--University of Pittsburgh, 2000. Graduate School of Public Health.